Role Overview
The C&Q Engineer will support the planning, execution, and documentation of commissioning and qualification activities for equipment, utilities, and processes within the Formulation and Component Preparation areas of a GMP-regulated manufacturing facility. This role ensures systems are delivered in compliance with regulatory standards and are fit for intended use.
Key Responsibilities
Preparation & attendance at FAT (e.g. parts washer, autoclave)
Develop and execute C&Q protocols for formulation vessels, mixing systems, component washers, autoclaves.
Collaborate with cross-functional teams (Engineering, QA, Operations) to ensure timely delivery of C&Q milestones.
Apply Quality Risk Management (QRM) principles to focus qualification efforts on critical systems.
Review and approve URS, design specifications, and test documentation.
Track and resolve deviations, change controls, and discrepancies during execution.
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